Amiloride Hcl


Amiloride Hcl

Drug - Amiloride Hcl
The trade name of the product as shown on the labeling.

The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Amiloride Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 5MG
The potency of the active ingredient(s), Amiloride Hydrochloride. May repeat for multiple part products.

Applicant - PAR PHARM
The firm name holding legal responsibility for Amiloride Hcl. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 070346
The FDA assigned number to Amiloride Hcl. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Amiloride Hcl. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - AB
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Jan 22, 1986
The date Amiloride Hcl was approved as stated in the FDA approval letter to the applicant. The format is Mmm dd, yyyy. Products approved prior to the January 1, 1982 contain the phrase: "Approved prior to Jan 1, 1982".

Reference Listed Drug (RLD) - No
The pioneer or innovator of Amiloride Hcl. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - RX
The group or category of approved drugs Amiloride Hcl is in. Format is RX, OTC, DISCN.

Applicant Full Name - Par Pharmaceutical Inc
The full name of the firm holding legal responsibility for the new application of Amiloride Hcl.

Amiloride Hcl